Providing software for services governed by a regulatory body may require adhering to a number of requirements that do not exist outside of the regulatory environment. Indeed, the cost (for example, in terms of money, time, or experience) of complying with such requirements often keeps some software suppliers from providing software to regulated markets.
The life sciences area is no exception. Regulatory markets involving, for example, clinical trials, toxicology, or environmental protection are often governed by regulatory bodies such as the FDA (Food and Drug Administration) or the EPA (Environmental Protection Agency) in the United States, and similar bodies in other countries. These agencies typically promulgate regulations that have the effect of making it difficult for software suppliers to provide software. For example, they may be unfamiliar with the regulations or may not have the infrastructure to provide software that complies with such regulations, and acquiring or developing such infrastructure may be too cost prohibitive.
In the clinical trials area, regulatory requirements coupled with legacy practices can make performing clinical trials difficult. Some of the legacy practices include submitting clinical trial results to regulatory authorities in paper form. One way that life sciences companies that perform clinical trials have tried to reduce their expense is to use software programs that make some submissions electronically. Regulatory authorities have promulgated rules and recommendations governing such electronic submissions, including electronic records and electronic signatures. In the United States, the FDA's rules that govern electronic records and electronic signatures are found in 21 CFR Part 11, which is designed to ensure that the electronic submissions are “trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.” 21 CFR §11.1. According to the FDA's Guidance for Industry regarding Part 11, Electronic Records; Electronic Signatures—Scope and Application (August 2003), “Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations (§11.1).” The FDA has also provided other guidance related to software, for example, in its General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 2002).
Software suppliers may desire to offer software programs or applications to lessen the expense of clinical trials in particular, and to improve performance in other regulatory areas. But the information generated by these software programs, in addition to satisfying the regulatory agencies' requirements related to the data themselves and the processes followed to collect the data, must abide by those requirements. Navigating these requirements can be laborious, and making sure that software is compliant often dissuades suppliers from generating regulatory solutions.
Where considered appropriate, reference numerals may be repeated among the drawings to indicate corresponding or analogous elements. Moreover, some of the blocks depicted in the drawings may be combined into a single function.